Non-invasive Diagnostics of Microbial Keratitis

NCT ID: NCT06364878

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2028-04-08

Brief Summary

Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration.

This project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film.

Using in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics.

The project aims are translated into the following hypotheses:

H1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results.

H2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis.

Conditions

Infectious Keratitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patents with suspected infectious keratitis

In vivo confocal microscopy

Intervention Type: DIAGNOSTIC_TEST

The patients cornea will be examined non-invasively by IVCM

Tear film sampling

Intervention Type: DIAGNOSTIC_TEST

Patients tear film will be collected and stored at -80 degrees for analysis

Healthy controls

In vivo confocal microscopy

Intervention Type: DIAGNOSTIC_TEST

The patients cornea will be examined non-invasively by IVCM

Tear film sampling

Intervention Type: DIAGNOSTIC_TEST

Patients tear film will be collected and stored at -80 degrees for analysis

Interventions

In vivo confocal microscopy

The patients cornea will be examined non-invasively by IVCM

Intervention Type: DIAGNOSTIC_TEST

Tear film sampling

Patients tear film will be collected and stored at -80 degrees for analysis

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

IVCM

Eligibility Criteria

Inclusion Criteria

• Clinically suspected infectious keratitis in patients over 18 years of age
• Patients with acceptable travel distance to the hospital
• Patients accepting to be part of the study

Exclusion Criteria

• Previously diagnosed infectious keratitis during the last 6 months
• Over 50 percent thinning of the cornea
• Previous use of antibiotics (other than Chloramphenicol)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Lagali

Role: PRINCIPAL_INVESTIGATOR

Sorlandet Hospital HF

Locations

Sorlandet hospital

Arendal, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Ingvild M Bakken

Role: CONTACT

ingvild.mygland.bakken@sshf.no

37014856

Facility Contacts

Neil Lagali

Role: primary

Other Identifiers

813533

Identifier Type: -

Identifier Source: org_study_id